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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K992518
Device Name PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
Applicant
Dentsply Intl.
570 W. College Ave.
York,  PA  17405
Applicant Contact P. JEFFERY LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
York,  PA  17405
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.3765
Classification Product Code
EBC  
Date Received07/28/1999
Decision Date 09/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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